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OpenTrials
Completed

NCT Number: NCT07176897

Refractive Accuracy of Toric Intraocular Lens Implantation Using Digital Marking Compared to Conventional Marking

To evaluate the postoperative refractive accuracy and intraoperative lens rotational placement of a conventional toric intraoperative marking method compared to digital marking.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Colvard-Kandavel Eye Center, Encino, California, United States

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About this study

Preoperative biometry and planning was assessed with the Argos SS-OCT biometer. The ToriCAM application was also used to mark the patient manually at the bedside. A Mendez marker was used to mark the final axis of the IOL, as calculated by Argos. Digital marking was performed using the VERION image guided system. All subjects received both digital and manual marking, and were implanted with Clareon monofocal toric IOLs (CCWOTx) using the digital marker for final IOL alignment. The primary outcome measure was the difference in degrees between the digital marker and the manual marker as measured intraoperatively. Other outcome measures included IOL rotation, residual astigmatism, absolute prediction error (APE), and monocular visual acuity at 2 months postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (50-90 years of age) that were candidates for uncomplicated cataract surgery and planned to be implanted with toric IOLs (CCWOTx, Alcon Vision, LLC)

Exclusion criteria

  • History of amblyopia
  • History of macular disease
  • History of glaucoma
  • History of corneal disease
  • History of prior corneal surgery
  • History of diabetes
  • History of ocular comorbidity that might hamper post operative visual acuity
  • History of previous ocular or refractive surgery with expected post-op VA worse than 0.10 logMAR
  • History of irregular corneal astigmatism and keratoconus, or severe/uncontrolled ocular surface disease or dry eye disease.

Treatment and study plan

Normal Toric IOL implantation with digital marking

Diagnostic Test

Digital marking was compared to bedside marking, but there was no change in clinical practice. The difference in the marks was measured.

Primary outcomes

  1. difference in degrees between the digital marker and the manual marker as measured intraoperatively

    Time frame: From enrollment to the end of post-operative period at 2 months

Secondary outcomes

  1. IOL rotation

    Time frame: From enrollment to the end of post-operative period at 2 months

  2. Residual Astigmatism

    Time frame: From enrollment to the end of post-operative period at 2 months

  3. Absolute Prediction Error (APE)

    Time frame: From enrollment to the end of post-operative period at 2 months

  4. Monocular Visual Acuity

    Time frame: From enrollment to the end of post-operative period at 2 months

Sponsors and collaborators

Lead sponsor

Colvard Kandavel Eye Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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